Benign Gynecologic NeoplasmNCT05710601
Effects of Tissue Sealers on Minor Laparoscopic Procedures Between Obstetrics and Gynecology Residents
An observational study of Benign Gynecologic Neoplasm, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
The kind of equipment used during laparoscopic surgery may have an effect on how quickly resident surgeons improve their skills. The effects of these technologies on various general and specialized procedures have been the subject of numerous research, all of which have produced comparable results in terms of efficacy… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Benign Gynecologic Neoplasm
- What is being tested?
- Laparoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2019to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Patients referred from the outpatient gynecological clinics of our unit who, according to national and international treatment guidelines, were eligible for a planned laparoscopic surgery.
Who may be able to join
- Senior gynecological surgeons
- At least 4 years of residency in gynecology
Who cannot join
- Junior residents, fellows, consultants
- Operative procedures due to malignancy
- Women who were not suitable for or denied a laparoscopic approach
- Declined the procedure
- Did not sign a written informed consent form
- Suffering from a gynecologic malignant disease or severe systemic illnesses
- Laparotomic conversion
Trial locations and contacts
1 site in 1 country.
About this study
The kind of equipment used during laparoscopic surgery may have an effect on how quickly resident surgeons improve their skills.
The effects of these technologies on various general and specialized procedures have been the subject of numerous research, all of which have produced comparable results in terms of efficacy and safety. Although a minimally invasive laparoscopy represents the gold standard method in over 70% of procedures for uterine and adnexal benign diseases, there is a paucity of evidence regarding the potential advantages or disadvantages of such kinds of devices in gynecologic laparoscopy.
Based on this, the purpose of this study was to determine whether using a hemostatic surgical device affects how quickly gynecology residents learn to execute simple laparoscopic procedures and how well they perform surgically.
- Conditions
- Benign Gynecologic Neoplasm
- Being tested
- Laparoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparoscopyProcedure or surgery
Operative laparoscopies carried out according to the most recent national guidelines and following the good clinical practice of our operative unit.
| Study group | Role | What they receive |
|---|---|---|
| Tissue sealers | Procedures performed using a 5 mm diameter, 35 cm length curved branch radiofrequency tissue sealer connected to a dedicated electric generator Receives: Procedure: Laparoscopy | |
| Bipolar forceps | Procedures performed using a 5 mm diameter, 35 cm classic rotating bipolar forceps Receives: Procedure: Laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vision of the surgical field
Numeric Rate Scale (NRS) 0-10 considering 0 for "inadequate vision" and 10 for "optimal vision"
Measured: 7 days
Interpretation of the difficulty of the intervention
NRS 0-10 (considering 0 for "extremely easy" and 10 for "extremely difficult")
Measured: 7 days
Secondary outcomes (2)
Overall procedural satisfaction
NRS 0-10 (considering 0 for "complicated or incomplete procedure" and 10 for "uncomplicated and satisfying intervention")
Measured: 7 days
Procedure time
Measured: Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start1 Mar 2019
- Primary completion1 Mar 2021
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Gynecologic NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaetano Riemma, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710601
- Sponsor's protocol ID
- 712-15-11-19
- Status last verified
- Jan 2023
- First submitted
- 14 Jan 2023
- Last updated
- 2 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tissue Sealers on Minor Laparoscopic Procedures Between Obstetrics and Gynecology Residents
- ClinicalTrials.gov ID
- NCT05710601
- Acronym / sponsor ID
- 712-15-11-19
- Conditions
- Benign Gynecologic Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The kind of equipment used during laparoscopic surgery may have an effect on how quickly resident surgeons improve their skills.
The effects of these technologies on various general and specialized procedures have been the subject of numerous research, all of which have produced comparable results in terms of efficacy and safety. Although a minimally invasive laparoscopy represents the gold standard method in over 70% of procedures for uterine and adnexal benign diseases, there is a paucity of evidence regarding the potential advantages or disadvantages of such kinds of devices in gynecologic laparoscopy.
Based on this, the purpose of this study was to determine whether using a hemostatic surgical device affects how quickly gynecology residents learn to execute simple laparoscopic procedures and how well they perform surgically.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tissue sealers | – | Procedure: LaparoscopyProcedures performed using a 5 mm diameter, 35 cm length curved branch radiofrequency tissue sealer connected to a dedicated electric generator |
| Bipolar forceps | – | Procedure: LaparoscopyProcedures performed using a 5 mm diameter, 35 cm classic rotating bipolar forceps |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients referred from the outpatient gynecological clinics of our unit who, according to national and international treatment guidelines, were eligible for a planned laparoscopic surgery.
Key inclusion criteria (2 listed)
- Senior gynecological surgeons
- At least 4 years of residency in gynecology
Key exclusion criteria (7 listed)
- Junior residents, fellows, consultants
- Operative procedures due to malignancy
- Women who were not suitable for or denied a laparoscopic approach
- Declined the procedure
- Did not sign a written informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaparoscopyOperative laparoscopies carried out according to the most recent national guidelines and following the good clinical practice of our operative unit. | Procedure or surgery | Bipolar forceps, Tissue sealers |
Primary outcome
Vision of the surgical field
Time frame: 7 days
Numeric Rate Scale (NRS) 0-10 considering 0 for "inadequate vision" and 10 for "optimal vision"
Interpretation of the difficulty of the intervention
Time frame: 7 days
NRS 0-10 (considering 0 for "extremely easy" and 10 for "extremely difficult")
2 secondary outcomes
Overall procedural satisfaction
Time frame: 7 days
Procedure time
Time frame: Procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Gynecologic Neoplasm, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vision of the surgical field (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.